Trial document




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  DRKS00008198

Trial Description

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Title

Normalization of sleep-dependent memory consolidation in boys with attention-deficit / hyperactivity disorder by acoustic stimulation during sleep

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Trial Acronym

aStim

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to examine whether memory problems in boys with ADHD can be normalized by acoustic stimulation of deep sleep.

Healthy children and adults show a better recall of previously learned content after sleeping one night between learning and retrieval. Deep sleep is primarily responsible for this effect. By contrast, children with ADHD do not seem to benefit from deep sleep and show poorer memory performance after sleeping. Recent studies have shown that hearing specific soft, short sounds during the night can improve memory performance in healthy adults. The acoustic stimulation enhances deep sleep, which explains the improved memory performance in healthy adults. In this study these soft, short sounds will be used to enhance deep sleep in boys with and without ADHD in order to improve their memory performance after sleep.

Twenty boys with ADHD aged 9-12 years as well as 20 healthy controls will be examined. Only children with an average IQ, a minimum average memory capacity, healthy sleep, and no mental health problems other than ADHD are included. The children spend a total of three nights in the sleep laboratory (consisting of one night to accustom themselves to the new surroundings, one stimulated night, and one control night without stimulation). During all three nights an EEG is used to record during sleep. In the evenings of the second and third nights, the children perform two learning tasks: the first task involves learning combinations of word pairs; the second task is a motor skills task.

During one of the two test nights, deep sleep is enhanced by the presentation of the above-mentioned sounds. On the other night, no such sounds are presented so that the depth of sleep is not manipulated. Each morning, following sleep, recall of the word pairs will be tested and the motor skills task will be performed a second time.

We expect that the presentation of sounds during sleep will adjust the memory performance of patients with ADHD to be more similar to the performance of healthy children without stimulation.

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Brief Summary in Scientific Language

This study is to show that deficits in sleep-dependent memory consolidation in boys with ADHD can be normalized by acoustically enhanced slow oscillations during sleep.

As shown in many studies, delta sleep supports the strengthening (consolidation) of declarative memory in healthy children and adults. Delta sleep is characterized by a high neuronal synchronicity and thus by a high-amplitude, low-frequency EEG activity (range <1 Hz, slow oscillations). Several studies point to a causal relationship between the amplitude of the slow oscillations and the sleep-dependent memory consolidation. For example the amplitude of slow oscillations has been strengthened by of transcranial direct current stimulation (tDCS) or with phase-accurate application of acoustic stimuli in delta sleep, which led to an increase in sleep-dependent memory skills.
Endogenous slow oscillations apparently don’t support the memory consolidation in children and adolescents with ADHD. However, the induction of slow oscillations using tDCS did normalize the sleep-associated memory consolidation in children with ADHD. The aim of this study is to stimulate endogenous slow oscillations in children with ADHD and healthy controls by presenting the well-tolerated acoustic stimulation and thereby to adjust the memory skills of children with ADHD towards the level of healthy children.

Twenty boys (9-12 years) with ADHD and a matched healthy control group (n = 20) will be examined. Exclusion criteria are below average intelligence, basic memory deficits, sleep disorders and other psychological disorders. In addition to the clinical diagnostic session, the study consists of three nights in the sleep laboratory with polysomnography monitoring (consisting of an adaptation night, a stimulation night, and a control night without stimulation). Slow oscillations in the delta sleep phase are detected online and enhanced in amplitude through the presentation of short sounds (55 dB, 50 ms bursts of 1 / f noise) through headphones. The acoustic stimulation is applied for 210 minutes.

A declarative memory task (paired associates learning task) as well as a motor memory task (serial reaction time task) are used to assess the memory consolidation. The encoding is done before sleep and the recall takes place the next morning.

Patients are expected to show a poorer memory consolidation compared to controls in the sham condition (Δ encoding - retrieval performance). Furthermore, it is expected that the consolidation performance is improved in both groups after stimulation compared to the sham condition. It is also expected that children with ADHD show comparable consolidation performance in the stimulation condition to healthy controls in the sham condition.

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Organizational Data

  •   DRKS00008198
  •   2015/05/19
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  •   yes
  •   Approved
  •   A 141/13, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   F90.0 -  Disturbance of activity and attention
  •   F90.1 -  Hyperkinetic conduct disorder
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Interventions/Observational Groups

  •   Patients with ADHD: acustic stimulation of deep sleep, one night at the sleep laboratory. Slow oscillations in the delta sleep phase are detected online and enhanced in amplitude through the presentation of short sounds (55 dB, 50 ms bursts of 1 / f noise) through headphones. The acoustic stimulation is applied for 210 minutes.
    Control night without stimulation.
  •   healthy controls: acustic stimulation of deep sleep, one night at the sleep laboratory as described in arm1.
    Control night without stimulation.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo, Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Memory performance in declarative and procedural memory task (declarative memory task (paired associates learning task) / motor memory task (serial reaction time task)), measured as memory loss or gain over night , each per night and per subject . Comparison between the two nights ( stimulation and control night ), all parameters also compared between the groups (patients, healthy controls)

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Secondary Outcome

physiological data (sleep parameters): percentage of slow wave sleep (stimulated vs. in non-stimulated night), amplitude of slow oscillations compared between the two nights , sleep spindles , comparing the percentages of the different sleep stages between nights . All parameters also compared between the groups of subjects (patients, healthy controls)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2015/07/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   9   Years
  •   12   Years
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Additional Inclusion Criteria

Intelligence in the average range ( IQ : 85-130 )
no short-term memory problems
no chronic diseases
Patient : No further diagnoses besides ADHD
Checks : no psychiatric diagnoses according to ICD - 10
no sleeping disorders

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Exclusion Criteria

under or above average intelligence range ( IQ < 85 or > 130 )
Short-term memory problems
chronic diseases
Patients : other diagnoses besides ADHD
Controls: psychiatric diagnoses according to ICD - 10
sleeping disorders

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Addresses

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    • Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
    • Niemannsweg 147
    • 24105  Kiel
    • Germany
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    • Klinik für Kinder- und Jugendpsychiatrie und -psychotherapieZentrum für Integrative PsychiatrieUniversitätsklinikum Schleswig-Holstein, Kiel
    • Mr.  Dr. rer. nat.  Alexander  Prehn-Kristensen 
    • Niemannsweg 147
    • 24105  Kiel
    • Germany
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    • Klinik für Kinder- und Jugendpsychiatrie und -psychotherapieZentrum für Integrative PsychiatrieUniversitätsklinikum Schleswig-Holstein, Kiel
    • Mr.  Dr. rer. nat.  Alexander  Prehn-Kristensen 
    • Niemannsweg 147
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Medizinische Fakultät der Christian-Albrechts Universität Kiel
    • Christian-Albrechts-Platz 4
    • 24118  Kiel
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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